Midiana #21

Midiana user manual

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Composition

In one tablet, covered. shell, contains 3 mg of drospirenone, 0.03 mg of ethinyl estradiol.As auxiliary substances used:    magnesium stearate (weight - 0.8 mg)    lactose monohydrate (48 mg)    corn starch (16 mg)    pregelatinized corn starch (9.6 mg)    Povidone To 25 (1.6 mg)    film shell (2 mg) - Opadry II white, and Colorcon 85G18490, which includes polyvinyl alcohol, soy lecithin, talc, titanium dioxide E 171 and macrogol No. 3350.

Form of issue

It is produced in white round biconvex round capsules, they are covered with film cover, on one side they have engraving "G63". For 21 tablets in a blister, 1, 3 blisters in a pack.

pharmachologic effect

Has a contraceptive effect with antiandrogenic and antimineralocorticoid properties.

Pharmacodynamics and pharmacokinetics

The contraceptive effect is based on the interaction of factors, among which the most important are inhibition of ovulation and structural and functional changes in the endometrium.Midianaa is a combined oral contraceptive due to such active substances as ethinyl estradiol and drospirenone. In addition, drospirenone in therapeutic dose has antiandrogenic and weak antimineralocorticoid properties, nevertheless, does not possess estrogenic, glucocorticoid, antiglucocorticoid activity, which gives drospirenone similarity in pharmacological profile to natural progesterone.Concerning pharmacokinetics: biotransformation of drospirenone and einilestradiol occurs in different ways. Drospirenone, when taken orally, is not completely absorbed, bioavailability is within 76-85% regardless of nutrition. Its maximum concentration after the first dose in the serum is 37 nanograms per ml in a few hours, in the first cycle, an equilibrium concentration of 60 nanograms per ml is established after 7-14 hours. Reduction in serum concentration occurs in 2 phases by binding to serum albumin.Metabolites of drospirenone are represented by acid forms formed during the opening of the lactone ring. The average apparent volume of distribution is about 3.7 liters per kilogram, the speed of metabolic. clearance - 1.5 ml / min / kg. The elimination process occurs exclusively in trace amounts in unmodified form, the metabolic products are excreted by the kidneys and through the intestine in an approximate ratio of 1.2: 1.4 with a half-life of 40 hours.In contrast to drospirenone, ethinyl estradiol is absorbed quickly and completely when taken orally, with an absolute bioavailability of 45%. The maximum concentration after the first dose is reached after several hours and is 30 μg. It has been established that a significant 1-pass effect occurs with a high individual variability, the apparent volume of the distribution is usually 5 liters per kilogram, approximately 98% of the compounds bind to plasma proteins. Ethinyl estradiol is able to induce the synthesis of globulin, binding sex hormones and transcortin in the liver. Metabolism occurs completely with the rate of metabolic clearance in 5 ml / min / kg, 0.02% of the dose enters the breast milk, the metabolic products are excreted by the kidneys and by the intestine in a stable ratio of 4 to 6 with the half-life of excretion of 1 day and the elimination half-life of 20 hours.

Indications for use

Contraception. Additional benefits for patients with puffiness, hormone-dependent fluid retention or weight gain, with seborrhea and acne.

Contraindications

Midiana Tablets can not be administered with the following conditions, and also requires the cancellation at the first development of them against the background of taking this medication:    hypersensitivity to constituents    thrombosis of deep veins, arteries or embolism of the pulmonary artery thrombus, and hereditary or acquired predisposition to them    myocardial infarction    various harbingers of thrombosis: transient ischemic attack (TIA) or angina pectoris    Atrial fibrillation, uncontrollable hypertension    complicated heart valve lesions    cerebrovascular diseases    surgical intervention with a long period of immobilization (immobilization)    smoking after 35 years    renal, hepatic insufficiency, liver tumor    risk factors for arterial thrombosis: severe arterial hypertension and dyslipoproteinemia, diabetes mellitus    hyperhomocysteinemia    pancreatitis, severe hypertriglyceridemia    deficiency: antithrombin III, protein C or S    severe forms and exacerbations of liver diseases until the normalization of liver samples    suspicion or established hormone-dependent malignant diseases of the reproductive system    bleeding from the vagina of incomprehensible origin    migraine    pregnancy or suspicion, breastfeeding    deficiency of the enzyme lactase, galactosemia, glucose-galactose malabsorption.With caution it is necessary to use for obesity, dyslipoproteinemia, controlled arterial hypertension, chloasma, postpartum period.

Side effects

Frequency of occurrence of a spectrum of by-effects: often - ≥ one per 100 to <one per 10 patients sometimes (infrequently) - ≥ 1/1000 to <1/100 rarely - ≥ 1/10000 to <1/1000 relative to organs and systems:    Nervous system: often - headaches and emotional lability, depression infrequently - a case of decreased libido rarely - there was an increase in libido.    Endocrine system: "often" - fixed pains in the mammary glands, cases of interruptions of the menstrual cycle, intermenstrual bleeding rarely - galactorrhea.    Sensory organs: rarely - cases of hearing loss, poor lens tolerance.    Digestive system: often - nausea, abdominal pain "Sometimes" arises - vomiting, diarrhea.    Skin: infrequent - acne, eczema, urticaria, knotty or multiform erythema, chloasma.    Cardiovascular system: sometimes - a change in either side of the blood pressure rarely - thrombosis, thromboembolism.    Complications of excretion: sometimes - fluid retention "Rarely" - weight loss was observed.    The immune system: rarely - bronchospasm.    Reproductive system: often - cases of acyclic vaginal bleeding (spotting spotting, breakthrough bleeding from the uterus), engorgement and enlargement of the mammary glands, candidiasis of the vagina infrequently, vaginitis rarely - galactorrhea, increased discharge from the vagina.

Instructions for use (Method and dosage)

Take the tablets inside, you can drink it with water (a small amount), every day (starting from the 1st day of the natural menstrual cycle, that is, menstrual bleeding) approximately at the same time in the sequence indicated on the blister: one tablet for 3 weeks, then a 7-day interval is required for the onset of menstrual bleeding.When replacing another combined oral contraceptive, vaginal ring, or transdermal patch, it is preferable to begin using Midiana the day after the last pill is consumed or on the day of removal of any of the previously used drugs.Midiana tablets can be taken from a mini-saw every day, on the day of removal of the implant or other intrauterine contraceptive, on the next injection day, while it is advisable to apply additional barrier methods of contraception in the first week.If the pregnancy was interrupted in the 1st trimester, then the reception is started immediately without additional contraceptive measures, if the pregnancy is interrupted in the 2nd trimester or the baby is born, then the reception begins in 3-4 weeks. A larger interval requires the use of additional barrier methods of contraception in the first week. If there is sexual intercourse, then first completely eliminate pregnancy or wait for the first menstruation.

The scheme for taking missed tablets

In case of delay in taking the tablet within 12 hours, the contraceptive protection of the drug will decrease, so it is recommended to take the pill immediately and continue with the usual procedure. If the delay was more than 12 hours, then in the further tactics of taking the drug should use 2 simple rules:    Stop taking the contraceptive for more than 1 week.    To achieve adequate oppression of the hypothalamic-pituitary system of ovarian function, a 7-day continuous intake of the drug is required.In daily practice, the following recommendations are useful:    In the first week, take the last missed dose as soon as possible, up to taking 2 tablets at a time. Further tablets are taken at the usual prescribed time, however, it is recommended to apply barrier methods of contraception for 7 days, otherwise the probability of pregnancy is possible, and it directly depends on the number of missed tablets and the proximity to the 7-day break.    In the second week, take the last missed dose as soon as possible and continue as usual. If the previous 7 days of admission were correct, then you can not use barrier contraception, but if more than 1 tablet is missed, then without them, sexual intercourse is not desirable.    The third week significantly increased the likelihood of reducing the contraceptive effect, this is due to the upcoming 7-day pass of taking the tablets. To prevent a decrease in contraceptive effect, it is possible to correct the schedule of taking the drug. If the previous 7 days. the course was not interrupted, it is possible to do without barrier contraception, otherwise it is necessary and it is necessary to act in one of two ways. First, you should take the drug as soon as possible and continue as usual, then - you need to start a new package without interruption between packages (most often bleeding cancellations are not observed, but there may be spotting or complications in the form of breakthrough uterine bleeding). Second: stop taking the pills from the current package for 7 days for withdrawal bleeding, including missed days of admission, then continue with the new package.In order to delay the bleeding cancellation, it is necessary not to stop taking the drug, that is, do not take a break between the packages. Delay may be until the end of the second package, but with lengthening the cycle, there may be spotting spotting from the vagina or complications in the form of breakthrough uterine bleeding. Then resume the reception, starting with the new pack after the standard 7-day interval. To postpone the onset of bleeding cancellation on a different day, it is necessary to shorten the nearest break by as much as necessary. Remember that the smaller the interval, the greater the risk of absence of bleeding cancellation and smearing bleeding (or complications in the form of breakthrough uterine bleeding) in the reception of the 2nd package.If the reception of Midiana tablets is accompanied by severe reactions on the part of the digestive tract, for example, vomiting or diarrhea, it means that the drug may not be absorbed completely, therefore it is recommended to additionally apply other contraceptive measures. If the attack of vomiting occurred after taking the pill after 3-4 hours, then you should take a new pill as soon as possible. If possible, the new tablet should be taken within 12 hours after the usual prescribed time of admission. If more than 12 hours have passed, then in the future it is necessary to act according to the rules of reception. If you do not plan to change the normal mode of reception, then take an additional one or more tablets from the next package.

Overdose

There have been no cases of overdose. Possible symptoms: nausea, vomiting, spotting or bleeding from the vagina. Prescribe symptomatic treatment. There is no specific antidote.

Interaction

Due to the interaction of oral contraceptives and other drugs, breakthrough uterine bleeding and / or a decrease in contraceptive protection may occur. The following types of interactions are known:    Phenytoin, barbiturates, carbamazepine, primidone, rifampicin (also similar to the effects of oxcarbazepine, topiramate, ritonavir, felbamate, griseofulvin, herbal remedies based on St. Johns wort, Latin Hypericum perforatum) can increase the clearance of sex hormones due to the induction of microsomal enzymes.    HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, Nevirapine) can influence liver metabolism.    Some antibiotics (penicillins, tetracyclines) reduce the intestinal hepatic recirculation of estrogen hormones, which can reduce the concentration of ethinyl estradiol.    Cyclosporine - an increase in the concentration of Midiana in plasma and tissues.    Lamotrigine - a decrease in the concentration of Midiana in plasma and tissues.    Perhaps the effect of this drug on individual laboratory tests, as well as biochemical indicators of liver, adrenal and kidney function, thyroid gland, on blood coagulation and fibrinolysis, on the concentration of plasma transport proteins (corticosteroid-binding globulin) lipid or lipoprotein fractions. It is important that the results are usually within the normal range.    Due to its insignificant antimineralocorticoid activity - there is an increase in the activity of the drug Renin and the concentration of mineralocorticosteroid hormone - aldosterone in the blood plasma.

Storage conditions

Inaccessible to children, dark place, at a temperature of no more than 25 ° Celsius.Shelf life Two years.

special instructions

If you take any of the drugs listed in the first 3 items of the "Interaction" section with this medicine, then you need to use barrier methods of contraception or completely switch to other contraceptives. If drugs containing active substances that affect microsomal liver enzymes are used, non-hormonal contraceptives should be used for 4 weeks after their withdrawal. When the concomitant drug is started at the end of the contraceptive package, the next packaging of the contraceptive is taken without a 7-day interval.

Midiana and overweight

No set of excess weight, sometimes there is a withdrawal of excess fluid. The drug does not affect the body weight. If there is such a side effect, it is better to consult a doctor.

With antibiotics

When taking antibiotics (except: Rifampicin, Griseofulvin), it is also necessary to temporarily resort to barrier methods of contraception for at least another 7 days after their withdrawal.

In pregnancy and lactation

During pregnancy and lactation, Median is contraindicated. If there was a pregnancy on the background of contraception, then immediately cancel the drug.There is little information on the lack of teratogenic effects and the increased risk to the child and woman during labor with the unintentional intake of combined oral contraceptives. In addition, they affect lactation, can reduce the amount and change the composition of breast milk, which can have a harmful effect on the child.

Reviews of Midiana

The doctors' comments about the Midiana are positive, they confirm the effectiveness of the drug as an oral contraceptive, so the drug is prescribed quite often. Regarding the reviews of patients - on the forums you can find a lot of different opinions. In most cases, they indicate the benefits of the drug: there is no effect on weight, skin, libido, it is also said about a high level of reliability, with one significant drawback - the drug can not be found in all pharmacies. However, in isolated cases, there are statements about the severity of addiction, headaches, digestive disorders, and others.